On July 15, 2023 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultra-rare diseases, reported the grant of 36,300 restricted stock units of the company’s common stock to 21 newly hired non-executive officers of the company (Press release, Ultragenyx Pharmaceutical, JUL 15, 2023, View Source [SID1234633244]). The awards were approved by the compensation committee of the company’s board of directors and granted under the Ultragenyx Employment Inducement Plan, with a grant date of July 16, 2023, as an inducement material to the new employees entering into employment with Ultragenyx in accordance with Nasdaq Listing Rule 5635(c)(4).

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The restricted stock units vest over four years, with 25% of the underlying shares vesting on each anniversary of the grant date, subject to the employee being continuously employed by the company as of such vesting dates.

On July 14, 2023 CEL-SCI Corporation (NYSE American: CVM) reported that it has concluded a productive meeting with the U.S. Food and Drug Administration (FDA) regarding the path forward for bringing Multikine* (Leukocyte Interleukin, Injection) immunotherapy to market for the treatment of newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN) (Press release, Cel-Sci, JUL 14, 2023, View Source [SID1234633246]). During the recent meeting, the FDA acknowledged the longstanding need for improved treatments for head and neck cancer.

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CEL-SCI believes the agency was collaborative and positive. Preliminary feedback from the FDA included that the selection criteria developed by CEL-SCI could be used to determine which patients should receive Multikine. Based on the feedback received at this recent meeting, CEL-SCI is preparing additional information about its development plan for the next meeting with the agency.

CEL-SCI is expecting scientific advice meetings with the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK in the fall of 2023. These are priority markets for CEL-SCI, as Europe has more than twice the number of head and neck cancer cases diagnosed each year as compared to the U.S.

The Company believes that it is even further along the regulatory path in Canada, as Health Canada already advised CEL-SCI earlier this year that it would be appropriate to request advance consideration for approval of Multikine under the Notice of Compliance with Conditions (NOCC) policy. If Health Canada grants the NOCC, then it is possible that CEL-SCI could begin commercialization in Canada as early as 2024.

Geert Kersten, CEO of CEL-SCI stated, "The almost 4-year median survival benefit and complete tumor elimination in some patients in just 3 weeks are very strong indications that we have a drug that can help patients with this horrible cancer. It is also important to note that 15.2% of the patients treated with Multikine exhibited a tumor response in only 3 weeks and patients who have a tumor response have an 82.2% survival at 5-years, compared to 48.6% for the control group. Tumor response has often been used in conditional approvals as an important indicator of the effectiveness of a treatment. A confirmatory clinical trial will be required by the FDA based on the agreed upon selection criteria for patients that will be treated with Multikine as assessed by methods including PET-CT/MRI screening. We will collaborate closely with the FDA to design a clinical protocol that will allow us to generate, as expeditiously as possible, the confirmatory data they require for approval of Multikine. This includes confirming the pre-surgical tumor responses that arise within just weeks of Multikine treatment in the agreed upon population. Our meeting with Health Canada earlier this year was also positive, and we are preparing our application for the NOCC approval as they suggested, which we hope to file later this year/early next year. Our planned meetings with the MHRA in Britain and the EMA in Europe will help us understand if a conditional approval can be given in those countries with a promise to do confirmatory studies after approval or if it is possible to get a conditional approval with the enrollment of just a small number of patients. Our goal is to obtain approval of Multikine worldwide and then make it available to patients as fast as possible."

Multikine is a neoadjuvant immunotherapy given to newly diagnosed head and neck cancer patients for three weeks immediately after diagnosis, before the standard of care (SOC) treatments of surgery and radiation, because that is when the immune system is still thought to be the strongest. The completed pivotal Phase 3 study demonstrated that patients who received Multikine followed by surgery and radiation reported a 5-year statistically significant overall survival (OS) absolute benefit of 14.1% in the intent to treat (ITT) subjects (n=380) who were categorized as lower risk for recurrence (LR) per National Comprehensive Cancer Network (NCCN) guidelines as compared to control LR subjects who received only SOC. With PET-CT/MRI, these subjects can be identified at screening to permit Multikine treatment before surgery.

On July 14, 2023 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its second quarter 2023 financial results and guidance will be released on Thursday, August 3, 2023 after the market closes (Press release, Gilead Sciences, JUL 14, 2023, View Source [SID1234633245]). At 5:00 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s second quarter 2023 financial results and provide a business update.

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A live webcast will be available on the Investor Relations section of www.gilead.com and will be archived there for one year.

On July 14, 2023 Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) ("Infinity"), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming drug candidate, reported that, based on a preliminary vote count, its stockholders have adopted the previously announced merger agreement providing for the merger with MEI Pharma, Inc. ("MEI") at the special meeting of Infinity stockholders held earlier today (the "Special Meeting") (Press release, Infinity Pharmaceuticals, JUL 14, 2023, View Source [SID1234633243]).

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The transaction remains subject to approval by MEI stockholders.

Final voting results for the Special Meeting will be disclosed on Form 8-K filed by Infinity with the U.S. Securities and Exchange Commission.

On July 14, 2023 ImmunoPrecise Antibodies Ltd. (NASDAQ: IPA) ("IPA" or the "Company"), an AI-driven biotherapeutic research and technology, reported to extend an invitation to investors and other interested parties to participate in an upcoming interview hosted by Market Radius Research (Press release, ImmunoPrecise Antibodies, JUL 14, 2023, View Source [SID1234633242]).

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Martin Gagel, founder of Market Radius Research, will join forces with Dr. Jennifer Bath, CEO of IPA, to delve into the intricate details of IPA’s revolutionary platform. IPA’s patented technology seamlessly integrates multiple modalities of biological data, multi-omics modeling, and artificial intelligence, a unique capability within the field of biotherapeutic research. Additionally, the interview will shed light on IPA’s in silico commercialization and market development strategies.

The event will be presented as a dynamic and interactive online webinar, offering attendees the opportunity to engage with the Company in real-time by posing questions following the interview. For those unable to join the event live on the designated day, an archived webcast will be made accessible for later viewing.

Don’t miss this exclusive occasion to gain valuable insights into ImmunoPrecise Antibodies’ groundbreaking advancements. Mark your calendars and join us on the webinar to witness the future of biotherapeutic research and development.

Event: Radius Research Pitch, Deep Dive and Q&A with ImmunoPrecise Antibodies

Presentation Date & Time: Wednesday, July 19th at 4 PM ET / 1 PM PT

Webcast Registration Link: View Source

The conference call will be webcast live and available for replay via a link provided in the Events section of the company’s IR pages at View Source

Market Radius Research gives individual investors access to in-depth CEO interviews with deep-dive institutional level discussion and Q&A. Market Radius is hosted by Martin Gagel, former top-ranked technology analyst. By registering for this webinar, you agree to receive email communications from Market Radius Capital, Inc. and from the presenting company (with unsubscribe). Your email will not be further shared. Martin Gagel and Market Radius Capital, Inc. are not registered or licensed to provide investment advice and may own shares in mentioned companies and may be compensated for these services. Content is for information purposes only and is not advice or recommendations and may include incomplete or incorrect information. Investing entails a high degree of risk. This is a production of Market Radius Capital, Inc.